UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017821 |
|---|---|
| Receipt number | R000020590 |
| Scientific Title | Single center, double-blind, randomized, parallel trial to evaluate the efficacy of rhizopus koji extract containing food in subjects with menopause symptom |
| Date of disclosure of the study information | 2015/06/24 |
| Last modified on | 2018/05/01 12:10:14 |
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Basic information
Public title
Single center, double-blind, randomized, parallel trial to evaluate the efficacy of rhizopus koji extract containing food in subjects with menopause symptom
Acronym
Evaluation study of the efficacy for menopause symptom
Scientific Title
Single center, double-blind, randomized, parallel trial to evaluate the efficacy of rhizopus koji extract containing food in subjects with menopause symptom
Scientific Title:Acronym
Evaluation study of the efficacy for menopause symptom
Region
| Japan |
Condition
Condition
menopause symptom
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of rhizopus koji extract containing food in improving menopause symptom after 4-week intake
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Kupffer man menopausal index ( Abe modification)
Key secondary outcomes
SDS,STAI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
rhizopus koji extract containing food
Interventions/Control_2
Placebo
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 45 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
(1)Japanese female ages 45-59 years old (inclusive)
(2)Subjects with Kupffer man menopausal index more than 23 scores
(3)Willing and able to provide signed written informed consent
Key exclusion criteria
(1)Subjects with severe hepatic, renal, cardiac, gastrointestinal, hematologic, endocrine and metabolic diseases / disorders
(2)Subjects with history of sensitivity to the ingredients
(3)Subjects who had participated in other clinical trials including drug and food within 1 month.
(4)Pregnant, lactating women or willing to be pregnancy during the study
(5)Any candidate considered to be unsuitable for enrollment in the opinion of the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Nishiyama |
Organization
Kaiyu Clinic
Division name
Kaiyu Clinic
Zip code
Address
3-3-6 Sagimiya, Nakano-ku, Tokyo
TEL
03-5356-6450
abe@kaiyuclinic.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Imai |
Organization
CROee Inc.
Division name
Evidence Division
Zip code
Address
1-13-23 Minami-Ikebukuro, Toshima-ku, Tokyo
TEL
03-5953-2108
Homepage URL
imai@croee.com
Sponsor or person
Institute
USHIKOSHI RESEARCH INSTITUTE FOR PHYSIOLOGY CO.,LTD.
Institute
Department
Personal name
Funding Source
Organization
USHIKOSHI RESEARCH INSTITUTE FOR PHYSIOLOGY CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
カイユウ診療所（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 05 | Day |
Date of closure to data entry
| 2015 | Year | 08 | Month | 26 | Day |
Date trial data considered complete
| 2015 | Year | 08 | Month | 26 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 05 | Day |
Last modified on
| 2018 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020590
